Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: ADCON-L ADHESION CONTROL IN A BARRIER GEL
• Generic Name: Inhibitor, peridural fibrosis (adhesion barrier)
• Applicant: Wrightmedicaltechnologyinc; 5677 Airline Rd.; Arlington, TN 38002
• PMA Number: P960057
• Supplement Number: S005
• Date Received: 02/19/1999
• Decision Date: 03/18/1999
• Withdrawal Date: 05/09/2007
• Product Code: MLQ
• Advisory Committee: Physical Medicine
• Supplement Type: 135 Review Track For 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Accepted for an eight-day holding period for filled syringes prior to sterilization.